DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (Figs. 1-2C) in the reply filed on 02/09/26 is acknowledged. The traversal is on the ground(s) that a search of the subject matter of Group I would not require a separate or additional search with respect to the claims of Groups II (Fig. 4) & III (Fig. 5). This is not found persuasive because:
Group I, claim 1 requires a second chamber distally adjacent the first chamber. Meanwhile, the Group II, claim 9 requires that a second chamber parallel the first chamber. These features in between Groups I & II require a separate or additional search. Group III, the process of mixing multiple constituents can be used in different product with respect to the device in Group I (claim 1) such as: a syringe device does not include a mixing chamber for mixing two constituents. Instead of that the syringe device has two mixing chambers; wherein the second chamber as a mixing chamber (when the first constituent of the first chamber enters into the second chamber for mixing two constituents).
Examiner stated on the Election/Restriction, page 5 that:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Note: claim 7 states that: the mixing chamber further comprises one of baffling and a piezo-electric actuator... This feature has been disclosed in non-elected Fig. 4. For example: the baffling is designated to element #450 (in Fig. 4); the elected Figs. 1-2C includes an auger implement for mixing two constituents. Meanwhile, claim 7 requires a piezo-electric actuator for mixing of the constituents. Nowhere in the specification states that two mixing mechanisms, i.e., an auger implement & a piezo-electric actuator are provided in the same syringe device system. In addition, the Figs. 1-2C does not include a piezo-electric actuator. Therefore, the claim 7 is withdrawn.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II & III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/09/26.
Claims 1-6 & 8 are being examined in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “the dry constituent is about 0.10 ml of a dry polymer...” is vague. In medical practice, the dry powder is kind of “fluffy” and does not occupy a standard volume like a liquid form. The dry powder (or dry constituent) should be measured by weight not volume because volume varies with compaction. A person skilled in the medical art would recognize that measuring dry power by volume-rather than by weight- leads to significant inaccuracy in dosage. This is due to the inherent, variable, and non-uniform nature of powders, which prevents volumetric measurement. For example: the fine-grained power is more compact (or occupied less volume) than large-particle power. Therefore, measuring dry power by volume is nonsensical.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Schreuder (US 4,792,329) in view of Mills et al. (US 3,606,094).
Regarding claim 1, Schreuder discloses a multi-chamber isolated constituent syringe into a patient. A person skilled in the art would recognize that the syringe in Schreuder can be used for eye surgery, as for intended use purpose for eye treatment;
the syringe 11, in Figs. 1-6 comprising:
a first chamber 22 for accommodating a first constituent 22;
a second chamber 21 distally adjacent the first chamber for accommodating a second constituent 21;
a mixing chamber (at chamber 27 & 30) distally adjacent the second chamber 21 to receive the constituents (liquid 21 & 22) for mixing therein;
a plunger rod 18; and
a needle 15 in fluid communication with the mixing chamber 27 & 30 for delivery of the combined mixed constituents into a patient and therefore, the combine mixed constituents can be injected into an eye of a patient as for intended use purpose for eye treatment.
Schreuder does not disclose a mixing mechanism of the syringe for reaching the mixing chamber.
Mills discloses a syringe device 1 in Figs. 1-9 comprising: a plunger rod 7; a mixing mechanism 2 (e.g. paddle projections 31) provided on the plunger 7; wherein the mixing mechanism of the syringe 1 is used for mixing in a chamber of the syringe.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Schreuder with including a mixing mechanism, i.e. paddle projections being attached to the plunger, as taught by Mills, in order to produce a uniform mixture of two constituents.
Regarding claim 3, Schreuder in view of Mills discloses all the claimed subject matter as required. Schreuder discloses that a syringe can be used to accommodate a solid medicament in the space between the separating stopper/barrier, col. 4, lines 50-57; wherein a lyophilized medicament (the solid medicament) is provided in a front chamber (similar to the second chamber 21 in Schreuder). In other words, Schreuder in view of Mills discloses the first chamber 22 is a wet chamber and the first constituent is a liquid and the second chamber 22 is a dry chamber and the second constituent is a dry constituent.
Regarding claim 4, Schreuder in view of Mills discloses all the claimed subject matter as required. Applicant states in the Background of the Invention that it is well-known in the art to form a retinal patch that include a mixture of different constituent components that, upon mixing a solid polyethylene power mix combine with a liquid polyethylene, para [0005] in the original specification of the current application. Therefore, a person skilled in the art would recognize that the syringe in Schreuder in view of Mills can be obtain a polymer solution in the first/liquid chamber and a dry polymer in the second/dry chamber.
With regarding the volume 2.0 ml of polymer solution and 0.10 ml of dry powder, the instant disclosure describes these parameters (2.0 ml of polymer solution and 0.10ml of a dry polymer) does not describe it as contributing any unexpected result to the mixture of two constituents. As such, these parameters are deemed matter of design choice for certain eye treatment, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
In addition, the retina patch size depends on the specific blend of liquid and dry polymers used, allowing for customized treatment based on the patient’s eyes repair need. Therefore, these parameters as required in the claim 4 is considered as intended use purpose.
Regarding claim 5, Schreuder in view of Mills discloses all the claimed subject matter as required. Schreuder in view of Mills discloses that the mixing chamber (at chamber 27 & 30) accommodated dedicated airspace of a volume (e.g., emptied space before mixture of the two constituents) tailored to the constituents for mixing.
Regarding claim 6, Schreuder in view of Mills discloses all the claimed subject matter as required. Schreuder in view of Mills discloses that wherein the mixing mechanism (as modified by Mills) is an auger implement 31 coupled to a plunger for breaching the barriers/separating stoppers with the constituents.
Regarding claim 8, Schreuder in view of Mills discloses all the claimed subject matter as required. Schreuder in view of Mills discloses that a dual depressor actuator 33 & 33 located on each side of the plunger 7 (as modified by Mills) at an external location of a housing 1 accommodating the chambers, the dual depressor actuator 33 configured to provide simultaneous surgical control over the mixing mechanism and a plunger 7 for directing the constituents to the mixing chamber.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schreuder (US 4,792,329) in view of Mills et al. (US 3,606,094) and further in view of Tan (US 7,43,237).
Schreuder in view of Mills discloses all the claimed subject matter as required. Schreuder in view of Mills discloses that the chambers are isolated from one another by barrier/stopper. Schreuder in view of Mills fails to disclose that the barrier/stopper are selected from a group consisting of medical foil, a pressure degradable membrane and a rupture disk.
Tan discloses a syringe comprising: a first chamber 280; a second chamber 290; wherein the chambers are isolated from one another by barrier 250 selected from a group of rupture disk, see Fig. 2E.
Since Schreuder and Tan are both from the same field of endeavor, the purpose disclosed by Tan would have been recognized in the pertinent art of Schreuder.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify barrier/stopper of the device of Schreuder in view of Mills with providing a weaken and rupture disk as being used as a separating barrier/stopper, as taught by Tan, in order to facilitate rapid displacement of the first constituent from the first chamber into the second chamber.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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